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Recruiting NCT06521099

A Novel Conditioning Approach to Counter Loneliness in Adults

No phase Interventional Loneliness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Evaluative Conditioning with positive stimuli, Conditioning with neutral stimuli.
Who it may be relevant to
Registry conditions: Loneliness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study aims to test the efficacy of a 6-session conditioning paradigm by investigating the conditioning-induced change in the socio-affective processing, loneliness, depressive symptoms, and neural correlates of lonely adults.

Detailed description

Potential participants will first be invited to complete a loneliness questionnaire online. Lonely adults will then be invited to undergo further screening. At baseline prior to the intervention training sessions, participants will first complete tests and questionnaires on loneliness, mood and depressive symptoms in addition to other socio-affective measures, and they will also be invited to receive resting-state functional MRI scanning in a 3T MRI scanner. Participants will then be allocated to one of the two intervention arms (the evaluative conditioning, and the control) in a randomized fashion with approximately half in each group. They will then complete the pre-conditioning phase of the allocated intervention arm, and their ratings on the stimuli presented during this phase will be assessed. In the conditioning phase, they will be invited to attend 6 sessions. After completing the conditioning phase, participants will be invited to complete the post- conditioning phase, providing ratings on the stimuli like the pre-conditioning phase. Immediately after, and also 3 months after, participants will be invited to complete again tests and questionnaires on loneliness, mood and depressive symptoms in addition to other socio-affective measures, and they will also be invited to receive resting-state functional MRI scanning in a 3T MRI scanner.

Interventions

  • Behavioral Evaluative Conditioning with positive stimuli
    In the pre-conditioning phase, participants will be exposed to pictures that vary in their emotional (negative, positive) and social (non-social, social) content. For each picture, they are required to indicate their immediate perceived valence (between negative to positive), degree of social motivation (between none to high) on Likert-scales. In the conditioning phase, emotional social pictures will be selected and paired with non-social positive stimuli for trials in random order, for 6 sessio
  • Behavioral Conditioning with neutral stimuli
    In the pre-conditioning phase, participants will be exposed to pictures that vary in their emotional (negative, positive) and social (non-social, social) content. For each picture, they are required to indicate their immediate perceived valence (between negative to positive), degree of social motivation (between none to high) on Likert-scales. In the conditioning phase, emotional social pictures will be selected and paired with with neutral non-social stimuli for trials in random order, for 6 se

Primary outcome measures

  • Self-reported loneliness [Time frame: Baseline, immediately after, and 3 months after the intervention]
  • Implicit loneliness [Time frame: Baseline, immediately after, and 3 months after the intervention]
Secondary outcome measures (5)
  • Valence of social stimuli [Time frame: Baseline, immediately after, and 3 months after the intervention]
  • Social motivation towards social stimuli [Time frame: Baseline, immediately after, and 3 months after the intervention]
  • Loneliness-related activation patterns and connectivity in neural networks [Time frame: Baseline, immediately after, and 3 months after the intervention]
  • Depressive symptoms [Time frame: Baseline, immediately after, and 3 months after the intervention]
  • Daily loneliness [Time frame: Through study completion, on average of 4 months]

Eligibility criteria

Inclusion criteria

  • No histories of learning impairment, major psychiatric disorders or neurological disorders other than depression
  • Normal intelligence
  • At least primary school education

Exclusion criteria

  • On medication or treatments within 2 weeks prior to the beginning of the study that would affect the individual's brain, cognitive and affective functions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The University of Hong Kong — Hong Kong

Publications

  • Wong NML, Lee TMC. Evaluating the effects of a conditioning training paradigm on loneliness, socio-affective processing, and brain connectivity: a study protocol of a two-arm randomised controlled trial. BMC Psychol. 2025 Aug 27;13(1):975. doi: 10.1186/s40359-025-03342-3. PMID 40866945

Identifiers

NCT: NCT06521099 · E2022-2023-0082

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗